A Robust And Scalable Strategy To Develop Amorphous Solid Dispersion Formulation For A Poorly Soluble Drug Substance

Low aqueous solubility is a significant hurdle in drug development, frequently resulting in reduced bioavailability and formulation difficulties. This case study highlights a strategic approach to overcoming these issues using amorphous solid dispersion (ASD) technology. A European biotech company partnered with Aragen to develop an oral formulation for a poorly soluble compound with less than 3% bioavailability. Through a structured four-week development program, the team identified an optimal polymer and surfactant, refined drug loading, and scaled up stable ASD formulations.

Using advanced screening techniques and characterization tools, such as PXRD, mDSC, and in vivo studies, the formulation achieved a substantial improvement in plasma drug concentration compared to conventional microsuspensions. The outcome illustrates how rational formulation design can transform low-solubility compounds into viable drug candidates ready for clinical advancement. Transforming solubility challenges into clinical opportunities begins with the right formulation strategy. Examine how this approach could benefit your program and unlock the potential of low-solubility compounds.